Notices. Notice
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/register/2007/02/27/07-882A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0480] Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance for industry entitled “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” In recent years, the practice of complementary and alternative medicine
(CAM)has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act. DATES: Submit written or electronic comments on the draft guidance by April 30, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0587. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” The term “complementary and alternative medicine”
(CAM)encompasses a wide array of health care practices, products, and therapies that are distinct from practices, products, and therapies used in “conventional” or “allopathic” medicine. In the United States, the practice of CAM has risen dramatically in recent years. In 1992, Congress established the Office of Unconventional Therapies, which later became the Office of Alternative Medicine (OAM), to explore “unconventional medical practices.” In 1998, OAM became the National Center for Complementary and Alternative Medicine (NCCAM). NCCAM is a center within the National Institutes of Health. The Institute of Medicine, in its book entitled, *Complementary and Alternative Medicine in the United States* , stated that more than one-third of American adults reported using some form of CAM and that visits to CAM providers each year exceed those to primary care physicians (see Institute of Medicine, *Complementary and Alternative Medicine in the United States* , pages 34 through 35 (2005)). As the practice of CAM has increased in the United States, we have seen increased confusion as to whether certain products used in CAM (which, for convenience, we will refer to as “CAM products”) are subject to regulation under the act or the PHS Act. We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act. (When the draft guidance mentions a particular CAM therapy, practice, or product, it does so in order to provide background information or to serve as an example or illustration; any mention of a particular CAM therapy, practice, or product should not be construed as expressing FDA's support for or endorsement of that particular CAM therapy, practice, or product or, unless specified otherwise, as an agency determination that a particular product is safe and effective for its intended uses or is safe for use.) The draft guidance makes the following two fundamental points: • First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. • Second, neither the act nor the PHS Act exempts CAM products from regulation. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the regulation of complementary and alternative medicine products by FDA. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: December 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-3259 Filed 2-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0020] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Oxygen Pressure Regulators and Oxygen Conserving Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.” The draft guidance document is intended to assist manufacturers in complying with minimum performance, testing, and labeling recommendations that are being proposed for these devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen into class II, subject to special controls. The proposal would also establish separate identification classifications for both oxygen pressure regulators and oxygen conserving devices, and would make those oxygen conserving devices that incorporate a built-in oxygen pressure regulator subject to special controls. This draft guidance is not final nor is it in effect at this time. DATES: Submit written or electronic comments on the draft guidance by May 29, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 1-800-638-2041. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 101, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Christy Foreman, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0120. SUPPLEMENTARY INFORMATION: I. Background This draft guidance provides FDA's recommendations to manufacturers for labeling and for determining ignition sensitivity and fault tolerance for oxygen pressure regulators. These devices are intended to convert medical oxygen pressure from a high variable pressure to a lower, more constant working pressure. The device is affixed to a pressurized container of oxygen and the regulator controls the gas flow. These devices are currently regulated as class I devices. However, FDA has received reports of fires and explosions associated with the use of oxygen pressure regulators resulting in serious injury to a number of equipment operators, including one fatality. The draft guidance, if finalized, would serve as the special control for these devices. FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the Federal Food, Drug, and Cosmetic Act (the act), would address the risks associated with oxygen pressure regulators and provide reasonable assurance of their safety and effectiveness. The draft guidance would also serve as a special control for oxygen conserving devices with a built-in oxygen pressure regulator; a device type already classified into class II under the generic device type noncontinuous ventilator (21 CFR 868.5905). FDA believes that conformance with the draft special controls guidance, when combined with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of oxygen conserving devices with a built-in oxygen pressure regulator. In the **Federal Register** of May 27, 2003 (68 FR 30214), FDA announced its intention to reclassify oxygen pressure regulators in its semi-annual regulatory agenda. FDA received one comment supporting the establishment of a proposed rule to reclassify these devices. II. Significance of the Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on oxygen pressure regulators and oxygen conserving devices with a built-in oxygen pressure regulator. It does not create or confer any rights for or on any person and would not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Pressure Regulators For Use With Medical Oxygen and Oxygen Conserving Devices,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document, or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1227 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E (premarket notification procedures) have been approved under OMB Control number 0910-0120. The labeling statements that would be required by this regulation are “public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public * * *” (5 CFR 1320.3(c)(2)). Accordingly, FDA concludes that the labeling requirements in this proposed rule are not subject to review by OMB under the PRA. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 8, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-3254 Filed 2-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration
(HRSA)publishes periodic summaries of proposed projects being developed for submission to Office of Management and Budget under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: The Nurse Faculty Loan Program (NFLP): Annual Operating Report
(AOR)Form—NEW Under Title VIII of the Public Health Service Act, as amended by Public Law 107-205, Section 846A, the Secretary of Health and Human Services
(HHS)enters into an agreement with a school of nursing to establish and operate the NFLP fund. HHS makes an award to the school in the form of a Federal Capital Contribution (FCC). The award is used to establish a distinct account for the NFLP loan fund at the school or is deposited into an existing NFLP fund. The school of nursing makes loans from the NFLP fund to eligible students enrolled full-time in a master's or doctoral nursing education program that will prepare them to become qualified nursing faculty. Following graduation from the NFLP lending school, loan recipients may receive up to 85 percent NFLP loan cancellation over a consecutive four-year period in exchange for service as full-time faculty at a school of nursing. The NFLP lending school collects any portion of the loan that is not cancelled and any loan in repayment and deposits these monies into the NFLP loan fund to make additional NFLP loans. The school of nursing must keep records of all NFLP loan fund transactions. The NFLP Annual Operating Report will be used to collect information relating to the NFLP loan fund operations and financial activities for a specified reporting period (July 1 through June 30 of the academic year). Participating schools will complete and submit the AOR annually to provide the Federal Government with current and cumulative information on:
(1)The number and amount of loans made,
(2)the number of NFLP recipients and graduates,
(3)the number and amount of loans collected,
(4)the number and amount of loans in repayment,
(5)the number of NFLP graduates employed as nurse faculty,
(6)NFLP loan fund receipts, disbursements and other related cost. The NFLP loan fund balance is used to determine future awards to the school. The estimate of burden for this form is as follows: Form Number of respondents Responses per respondent Total responses Hours per responses Total burden hours Nurse Faculty Loan Program Annual Operating Report
(AOR)150 1 150 8 1200 Total Burden 150 1 150 8 1200 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: February 21, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3406 Filed 2-26-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995 Pub. L. 104-13), the Health Resources and Services Administration
(HRSA)will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain the data collection plans, call HRSA Reports Clearance Office on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Scholarships for Disadvantaged Students Program—(OMB No. 0915-0149) Application—Reinstatement The Scholarships for Disadvantaged Students
(SDS)Program has as its purpose the provision of funds to eligible schools to provide scholarships to full-time, financially needy students from disadvantaged backgrounds enrolled in health professions and nursing programs. To qualify for participation in the SDS program, a school must be carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including students who are members of racial and ethnic minority groups (section 737(d)(1)(B) of the PHS Act). A school must meet the eligibility criteria to demonstrate that the program has achieved success based on the number and/or percentage of disadvantaged students who graduate from the school. In awarding SDS funds to eligible schools, funding priorities must be given to schools based on the proportion of graduating students going into primary care, the proportion of underrepresented minority students, and the proportion of graduates working in medically underserved communities (section 737(c) of the PHS Act). The estimated response burden is as follows: Form Number of respondents Responses per respondent Hours per response Total hour burden Application 500 1 20 10,000 Report 500 1 1 1,500 Total 500 1 21 11,500 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: February 21, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3407 Filed 2-26-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Draft Policy Document for Comment AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of availability and solicitation of comments. SUMMARY: This is a Notice of Availability and request for comments on the draft policy document, “Emergency Management Program Expectations,” prepared by HRSA. This document is currently posted on the Internet at *http://bphc.hrsa.gov* . Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments. DATES: Comments must be received by April 13, 2007. ADDRESSES: Please send your comments to the following e-mail address: *DPDgeneral@hrsa.gov.* *Background:* HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. In the August 29, 2006, **Federal Register** , HRSA announced its plan to periodically, as appropriate, solicit comments on some policies and policy documents via the HRSA Web site. The Emergency Management Program Expectations document is being posted as part of the implementation of this plan. SUPPLEMENTARY INFORMATION: For additional information on this process, see the HRSA notice in the August 29, 2006, **Federal Register** (71 FR 51200). Dated: February 16, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-3260 Filed 2-26-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration HIV/AIDS Bureau Policy Notice 99-02; Correction AGENCY: Health Resources and Services Administration, HHS ACTION: Correction of policy effective date. SUMMARY: The Health Resources and Services Administration published a notice in the **Federal Register** of December 6, 2006, soliciting comments on a proposed amendment to Policy Notice 99-02 which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006. The amendment also specifies a requirement that the need for such assistance must be certified or documented by a case manager, social worker, or other licensed health care professional(s). HRSA received over 150 substantive comments from consumers and numerous organizations around the country in response to the December 6, 2006, notice. Correction In the **Federal Register** of December 6, 2006, FR Doc. E6-20556, on page 70781, in the second column, first paragraph, last sentence: Remove the following text: “This policy becomes effective March 1, 2007” and insert the following text: “In order for HRSA to consider all public comments, it will delay the implementation of the proposed policy amendment until further notice.” Dated: February 22, 2007. Elizabeth M. Duke, Administrator. [FR Doc. 07-882 Filed 2-22-07; 2:09 pm]
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- 44 USC 3501-3520
- 21 CFR 807
- 5 CFR 1320.3(c)(2)
- Pub. L. 104-13
- Pub. L. 107-205
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cites case law
Notices
Notice
Cite44 USC 3501-3520
Cite21 CFR 807
Cite5 CFR 1320.3(c)(2)
Pub. L.Pub. L. 104-13
Pub. L.Pub. L. 107-205
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